MediciNova, in partnership with researchers at the University of California, Los Angeles (UCLA), US, is set to begin a clinical trial to investigate MN-166 (ibudilast) as a potential treatment for individuals diagnosed with alcohol use disorder (AUD).
The randomised, outpatient trial aims to enrol 50 non-treatment seeking individuals with moderate-to-severe AUD.
The trial will be funded by the Center for Study of Opioid Receptors and Drugs of Abuse (CSORDA), and will identify whether MN-166 is more effective for those patients who experience withdrawal-related dysphoria than those who do not experience withdrawal.
During the trial, the subjects will be stratified based on presence or absence of withdrawal-related dysphoria and will be randomly assigned to a 14-day treatment period to receive repeated oral doses of either MN-166 escalated up to 100mg/day or placebo.
Related
The study researchers will conduct Ecological Momentary Assessment (EMA) each day, a research technique which allows the examination of dynamic processes associated with depression and depression-related phenomena.
Throughout the treatment, subjects will take MN-166 and will report on their alcohol craving, as well as mood surveys and standard safety tests.
The trial’s major outcomes include whether MN-166 minimises basal level negative affect during abstinence, and in doing so, will interfere with alcohol-induced blunting of negative affectivity as captured during naturalistic drinking episodes.
The study principal investigator Lara Ray said: “The interplay between affect, withdrawal, and response to MN-166 in this population is an intriguing one.”
MediciNova’s MN-166 is currently available in Japan and South Korea for the treatment of post-stroke complications and bronchial asthma.
The company aims to develop the solution for various neurological conditions, including progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and substance abuse disorder.
Related Companies
